Data Mining and Analysis of ADE Signal for Sorafenib Based on the Data-base of FAERS
OBJECTIVE To mine and analyze the adverse drug reaction(ADE)signal for soradenib,and to provide reference for clinical safe drug use.METHODS A total of 72 quarterly adverse reaction reports from the fourth quarter of 2005 to the third quarter of 2023 were collected from the FDA adverse events reporting system(FAERS)database.The ADE reports caused by sorafenib were mined and analyzed using the reporting odds ratio(ROR)method and proportional reporting ratio(PRR)method.RESULTS A total of 18148 ADE reports of sor-afenib were collected,and a total of 689 effective ADE signals were detected,involving 26 systematic and organ clas-sifications,mainly focusing on gastrointestinal disorders,general disorders and administration site conditions,skin and subcutaneous tissue disorders.The top 3 ADE frequency were diarrhea(n=2741),hand-foot skin reaction(n=2097)and rash(n=1587).The top 3 ADE intensity were abnormal prothrombin elevation(ROR=326.03),alpha-fetoprotein elevation(ROR=189.82)and hand-foot skin reaction(ROR=75.10).The majority of ADEs occurred within 30 days of sorafenib administration.CONCLUSION Patient medication should be evaluated when sorafenib is used.During treatment,patients'gastrointestinal and skin reactions should be closely monitored to ensure safe med-ication.
SorafenibAdverse eventSignal miningReporting odds ratio methodProportional reporting ratio method
万方数据
维普
